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Prospective Real-World Study of Pathology AI for Glioma Molecular Prediction

A Prospective Real-World Study of Pathology Artificial Intelligence for Predicting Molecular Alterations in Gliomas

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07263711
Enrollment
2000
Registered
2025-12-04
Start date
2025-09-01
Completion date
2030-09-01
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

Brief summary

The goal of this clinical study is to learn if an artificial intelligence (AI) model can accurately predict important molecular changes in gliomas, a type of brain tumor, using digital pathology images. The main questions this study aims to answer are: How accurate is the AI model in predicting key molecular alterations compared with standard molecular testing? Can the AI model shorten the time needed for diagnosis and reduce the need for expensive molecular tests? Researchers will collect whole slide images from multiple hospitals and use the AI model to predict molecular results. The predictions will be compared with the actual test results from standard laboratory methods. Participants will: Allow the use of their pathology images and molecular test results for research. Have no additional treatments or procedures beyond standard medical care. This study will help determine whether AI-assisted tools can provide faster and lower-cost molecular diagnosis for glioma, improving patient care and supporting equal access to precision medicine.

Interventions

None listed

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Participant (or legally authorized representative) has voluntarily signed the informed consent form. * Age ≥ 18 years at the time of enrollment. * Histologically suspected diffuse glioma based on biopsy or surgical resection. * Availability of complete clinical information and usable digital pathology slides with hematoxylin and eosin (H&E) staining. * Postoperative molecular pathology results available for comparison.

Exclusion criteria

* Poor-quality pathology samples (e.g., insufficient tissue, large folding or contamination of slides, or substandard digital scanning quality). * Determined by the investigator to be unsuitable for participation in the study for any reason.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of AI model in predicting key molecular alterations in gliomaWithin 1 week after whole slide images (WSIs) are obtainedThe primary outcome is the diagnostic performance of the AI-based pathology model in predicting key molecular alterations in glioma. Accuracy, sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) will be calculated by comparing AI predictions with reference results from standard molecular pathology testing.

Countries

China

Contacts

Primary ContactDANYI LI
lidanyi26@163.com+8613538308634

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026